QA CTO Label Specialist
ECLARO
Summit, NJ
Job Number: 25-05569
Be part of a company that delivers life-changing healthcare solutions. ECLARO is looking for a QA CTO Label Specialist for our client in Summit, NJ.
ECLARO’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
Position Overview:
- The Label Control Specialist at the Client manufacturing facility is responsible for supporting site Label Control activities at Client in accordance with Client policies, standards, procedures and Global cGMPs.
- Functional responsibilities include performing in process and drug product label printing activities; ensuring accurate and timely issuance of labels for manufacturing and packaging labeling activities for Cell Therapy Development and Operations (CTDO).
- Label Control organization is responsible for the establishment, maintenance and continuous improvement of the clinical and commercial label control process, procedures, and responsibilities for achieving quality policies and objectives.
- This organization supports the Client facility to ensure patient safety, regulatory requirements and improve its effectiveness and efficiency on a continuous basis.
Pay Rate: $37.00/Hour
Responsibilities:
- Supports all activities for the Label Control group.
- Responsible for issuing clinical and commercial in-process and final product labels for labeling operations.
- Responsible for ensuring accurate printed information on labels in compliance with health authority requirements.
- Coordinates with production teams to ensure timely issuance of labels.
- Performs training of label control and issuance requirements for internal personnel as needed.
- Ensures standard operating procedures (SOPs) related to job responsibilities define the steps necessary to complete tasks, etc. Writes, reviews and updates SOPs as required.
- Carries out plans and actions to support new drug product launches, new market and other quality management activities as assigned.
- Provides support during internal and health authority inspections and audits of facility.
- Knowledge of quality processes, including label control and issuance, change control, product complaints, deviations, investigations and CAPA management.
- Performs supplemental investigations/projects as required by Management.
- Maintains knowledge of current GMPs and regulatory guidelines.
Required Qualifications:
- Education and Experience: B.S. Degree required, minimum 2 years relevant work experience.
- Must Haves: deviations, CAPA, SOP writing, Project Management, Pharma background.
- Must have knowledge and experience with GMP, Quality, and compliance.
- Able to write and review technical reports with clarity and brevity; provides guidance to other team members in technical writing skills.
- Requires moderate direction to complete more complex tasks; completes routing tasks with little or no supervision.
- Must be time organized and possess an independent mindset.
- Good understanding of electronic document management and manufacturing execution systems.
- Has advanced computer skills to increase department's productivity, as well as broadening technical and scientific knowledge.
- Confident in making decisions for non-routine issues.
- Routinely recognizes and addresses quality opportunities to improve overall process/project efficiencies.
- Proposes solutions for complex issues and works with management to resolve.
- Follows established procedures and performs work as assigned.
- Builds relationships and effectively communicates internally within the function and with internal and external cross-functional teams.
- Interacts with internal and external cross functional teams.
- Represents department in internal and external cross-functional teams.
- Contributes to goals within the work group.
- Able to recognize conflict and notify management with proposed recommendations for resolution.
- Able to prepare written communications and communicate problems to management with clarity and accuracy.
- Able to produce data reports with precision.
- Able to multi-task.
- Able to support internal and health authority inspections of facility
If hired, you will enjoy the following ECLARO Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through ECLARO
If interested, you may contact:
Paul Quibuyen
Christian.Quibuyen@eclaro.com
6466952942
Paul Quibuyen | LinkedIn
Equal Opportunity Employer: ECLARO values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status, in compliance with all applicable laws.
About the Company
ECLARO
Eclaro is a Business and Technology Consulting Firm that connects top talent with opportunities nationwide. We have direct access to Hiring Managers from leading Fortune 1000 organizations in almost every industry segment, with particular expertise in:
• Technology and Business Consulting
• Financial Services and Insurance
• Pharmaceuticals and Life Sciences
• Consumer Products, Public Sector, and Utilities
Eclaro provides fully customizable, comprehensive talent acquisition and management of seasoned professionals through a number of business models, including:
• Consulting
• Professional Hiring
• Global Integrated Delivery™
• Managed Services
Eclaro recruits and manages a staff of highly skilled individuals in an array of specialized disciplines enabling our clients to leverage new opportunities, respond to increased and changing demands, and increase their profitability.
Eclaro’s Management Team averages over 25 years of experience in partnering with clients in technical, corporate operations and human capital solutions. We hold ISO 9001:2008 certification and have achieved SOC 2 Type 2 certification in Security, Availability and Confidentiality. Eclaro’s decades of expertise and collaborative practice have proven that The Right People are The Answer.